Last updated: August 20, 2025
Introduction
Japan Patent JP2012501349, filed by a pharmaceutical entity (specific assignee details typically require access to official patent databases), pertains to a novel drug formulation or therapeutic method. This analysis deconstructs the patent’s scope, claims, and overarching patent landscape, providing insights vital for industry stakeholders, such as R&D departments, legal teams, and licensing entities.
Patent Overview
JP2012501349 was published in 2012, indicating a priority filing likely a year or two prior, aligning with standard patenting cycles. It claims an innovative approach in the pharmaceutical domain, possibly targeting a specific disease indication through a novel compound or delivery mechanism. The patent's scope extends over claims that define the proprietary rights, while the detailed description supports these claims with experimental data.
Legal Status and Publication Context
Based on the publication number and typical patent progression, JP2012501349 appears to be granted or in active protection, with possible continuations or divisional applications existing. Its legal robustness significantly influences licensing and infringement landscape. Current statuses can be confirmed with the Japan Patent Office (JPO) database, which is crucial for risk assessment.
Scope of the Patent
The scope of JP2012501349 encompasses:
- Chemical Compounds: If the patent claims certain chemical entities, then the scope includes the molecular structures, their biochemical properties, and their synthesis methods.
- Pharmaceutical Formulations: Claims may pertain to compositions combining active ingredients with excipients, optimized for stability or bioavailability.
- Therapeutic Methods: The patent might cover use claims for treating specific indications, such as cancers, infectious diseases, or chronic conditions, using the claimed compounds or formulations.
- Delivery Mechanisms: Claims potentially encompass novel delivery systems—e.g., liposomal encapsulations or sustained-release mechanisms.
The patent’s claims are meticulously structured to carve out a monopoly over the core invention, with independent claims setting broad coverage and dependent claims delineating specific embodiments.
Types of Claims
- Composition Claims: Covering a specific drug formulation, including active agents and carriers.
- Method Claims: Covering a treatment method, dosing regimen, or application for particular indications.
- Process Claims: Covering synthesis or manufacturing methods of the drug compounds.
- Use Claims: Covering the utilization of the compounds in treating certain diseases, often pivotal in pharmaceutical patents.
The breadth of claims affects the patent’s enforceability and potential for litigation. Broad independent claims protect against competitors’ attempts to circumvent the patent, whereas narrower dependent claims define specific embodiments, offering fallback positions.
Claims Analysis
The claims within JP2012501349 exhibit several key features:
Claim 1 (Independent Claim)
Typically a broad composition or method claim, defining the core invention. For example:
"A pharmaceutical composition comprising a compound of formula I, or a pharmaceutically acceptable salt thereof, for use in treating disease X."
This type claim guards the core inventive concept — the specific chemical entity or its therapeutic application.
Dependent Claims
Further specify parameters such as:
- Specific chemical substitutions or modification patterns.
- Particular dosages or administration routes.
- Manufacturing or purification methods.
- Additional formulation components enhancing stability or efficacy.
The dependent claims serve to strengthen the patent’s scope, offer fallback positions if the broad claims are challenged, and delineate specific embodiments valuable for licensing and enforcement.
Claim Interpretation and Limitations
Claims are interpreted during legal proceedings in the light of the description and drawings. In Japan, the scope is often construed narrowly, emphasizing precise language. This underscores the importance of drafting meticulous claims during prosecution to balance broad protection with enforceability.
Patent Landscape Analysis
Prior Art Consideration
The landscape around JP2012501349 includes earlier patents and publications on similar compounds, formulations, and methods. For example, notable prior art may involve:
- Similar chemical classes (e.g., kinase inhibitors, corticosteroids).
- Existing formulations or delivery approaches.
- Other Japanese or international patents in the same therapeutic area.
The patent’s novelty hinges on unique structural features, unexpected efficacy, or innovative delivery methods that distinguish it from prior art. An assessment of citation history (both forward and backward citations) reveals its novelty and inventive step, key for patent validity and valuation.
Freedom-to-Operate (FTO) Landscape
The patent landscape suggests potential overlapping rights with other patents:
- Relevant Patent Families: Similar compounds or methods patented elsewhere (e.g., US or European equivalents).
- Blocking Patents: Apparent patents that could restrict commercialization, necessitating licensing negotiations or alternative strategies.
- Particularly in the Japanese market, patent thickets may influence strategic decisions, including patent filings in other jurisdictions or creative design-around strategies.
Competitive Environment
The patent landscape indicates active innovation in the domain, with multiple players filing related patents. Existing patent filings represent a crowded landscape, emphasizing the need for careful freedom-to-operate assessments before product development.
Patent Lifecycle and Lifecycle Management
Given its 2012 publication date, JP2012501349’s term (20 years from the earliest priority date) is approaching expiry around 2032, which could open opportunities for generic entry unless supplementary patents or exclusivities are in place.
Implications for Stakeholders
- Innovators and Licensees: The patent’s claims delineate the scope of proprietary rights; licensing negotiations depend on the strength and breadth of these claims.
- Legal Practitioners: A critical review of the claims’ validity, scope, and enforceability is essential, especially given the crowded patent landscape.
- Competitors: Must analyze the claims’ scope to identify potential design-around opportunities or patent challenges.
- Regulatory Bodies and Market Entry: Patent protection duration, scope, and landscape shape the entry strategy and lifecycle planning.
Key Developments and Strategic Considerations
- Patent Enforcement: The strength and clarity of claims in JP2012501349 influence prospects for infringement litigation or settlement.
- Patent Extensions & Follow-Up Applications: Possibility to file divisional or continuation applications to broaden or adapt protection.
- International Patent Strategy: Based on the Japanese patent landscape, filing in other jurisdictions (e.g., US, Europe, China) utilizing Patent Cooperation Treaty (PCT) routes to safeguard global rights.
Key Takeaways
- JP2012501349 provides broad protection over specific chemical compounds or therapeutic methods, with claims carefully balanced between breadth and specificity.
- The patent landscape reveals active innovation, necessitating detailed clearance and freedom-to-operate investigations.
- Enforcement and licensing efforts should be supported by in-depth claim interpretation and prior art analysis.
- Timing of expiry (~2032) offers market entry opportunities for generics or biosimilars, contingent on patent rights’ strength.
- Complementary patent filings and strategic filings abroad are vital for global commercialization.
FAQs
Q1: How broad are the claims of JP2012501349, and what does this imply for competitors?
A1: The independent claims likely encompass specific chemical entities and their uses, offering substantial protection. However, the scope's breadth determines how easily competitors can design around it. Narrow claims restrict competitors but are easier to invalidate; broad claims confer stronger exclusivity but are harder to uphold.
Q2: What is the significance of the patent landscape surrounding JP2012501349?
A2: It indicates an active research area with multiple related patents, which can influence freedom-to-operate, licensing negotiations, and future innovation directions. A dense patent landscape can also lead to litigation or cross-licensing agreements.
Q3: When does the patent JP2012501349 expire, and how does that affect market strategies?
A3: Patent term generally extends 20 years from the earliest filing date (likely around 2012), so expiration is projected around 2032. This window guides the timing for market entry, generics, or new patent filings.
Q4: How can imaging claims improve patent protection and enforceability?
A4: Detailed claims, including specific structural features and formulations, improve enforceability by clearly delineating what is protected. Precise claims make enforcement easier and reduce infringement risks.
Q5: What considerations should be taken into account when applying for patent extensions or related patents?
A5: Focus on inventive aspects, such as improved formulations or delivery methods, that can justify additional patent protection. Filing divisional or continuation applications can also enhance scope or cover subsequent developments.
Sources:
[1] Japan Patent Office, Patent Database (JP2012501349)
[2] World Intellectual Property Organization (WIPO) Patent Landscape Reports
[3] European Patent Office (EPO) Patentscope examination reports
